Emprove® Dossiers for Chemicals

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Three Levels of Information for Starting and Raw Materials

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All our subscribers to the Emprove® Suite get online access to all dossiers of the entire Emprove® portfolio for two years.

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To address evolving regulatory requirements, we are constantly developing our Emprove® dossier library to better meet your challenges. The information on our Emprove® Evolve, Emprove® Essential and Emprove® Expert products is organized into three types of dossiers. Each dossier’s name indicates where it can be used to facilitate your material qualification, risk assessment and process optimization efforts.

  • The Material Qualification Dossier supports material qualification and speeds up drug filing preparation. It includes content on manufacturing processes, product characterizations, certificates, justification, stability summary, and more.
  • The Quality Management Dossier supports risk assessment according to ICH Q9 and EU 2015/C95/02 by offering extended information on the supply chain and Quality Management System as well as stability data.
  • The Operational Excellence Dossier supports process optimization activities around Elemental Impurities (ICH Q3D), Product Quality Reports, and Analytical Procedures.

Learn more about our different Emprove® Categories How Emprove® Dossiers for Chemicals can support you

Emprove® Dossier Library for Raw and Starting Materials

Dossier NamePurpose of DossierPriceContent
Material Qualification Dossier Information to start a material qualification

In line with CTD chapter 3 quality (adapted for excipients)
Free of charge*
  • General information
  • Manufacture
  • Characterization
  • Control of drug substance
  • Reference standard
  • Materials
  • Container closure system
  • Stability summary
Quality Management Dossier

Demo Dossier

Answers questions during risk assessment 5,500 €
  • Product quality self-assessment
  • Audit report summary
  • Supply chain information
  • Stability data**
Operational Excellence Dossier

Demo Dossier

Supports process optimization 3,200 €
  • Product quality report
  • Elemental impurities information
  • Analytical procedure
Subscribe to Emprove® Suite Full Access to all dossiers of the Emprove® Library 20,000 €
  • One time registration
  • Includes 5 email addresses per company
  • Access for 2 years
  • Additional accesses can be purchased

*The Material Qualification Dossier is free of charge and available on the specific product detail pages of our website after log-in. It can also be downloaded through the Emprove® Suite.

**Availabe for Emprove® Evolve, Emprove® Essential and Emprove® Expert products only

To learn more about our dossiers for filters and single-use components please click here